Dapagliflozin added to standard care for active lupus nephritis
Official title: Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis
Run by Brigham and Women's Hospital · NCT07323524 · Data updated 2026-11-12
A 12-week pilot trial will test whether adding dapagliflozin to standard lupus nephritis treatment helps people with active disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | belimumab, cyclophosphamide, prednisone |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | May 22, 2026 |
| Main results expected | July 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07323524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with active, biopsy-proven lupus nephritis (classes III/IV/V) who are on standard immunosuppressive therapy and meet the study criteria.
✕Probably not a fit
Patients with severely reduced kidney function (GFR < 25 mL/min/1.73 m2) or acute kidney injury at enrollment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a small, randomized, double-blind, placebo-controlled study evaluating dapagliflozin 10 mg daily added to standard therapy for adults with active, biopsy-proven lupus nephritis (classes III/IV/V). Participants are randomized 2:1 to dapagliflozin or placebo for 12 weeks, with follow-up through 12 months using routine lab data. Primary goals include enrollment feasibility, data-collection practicality, changes in urine protein-to-creatinine ratio, and safety including rates of serious adverse events and genitourinary infections. The trial uses concealed allocation and standard-of-care backgrounds to assess whether the SGLT2 inhibitor provides additional kidney protection in this population.
Why it matters
Potential benefit: If successful, adding dapagliflozin could improve kidney outcomes for people with active lupus nephritis.
How similar studies have gone: Previous studies suggest SGLT2 inhibitors can help kidney disease; this represents a novel application in active lupus nephritis and is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* • Age 18-70 years, fulfilling 2012 SLICC or 2019 ACR/EULAR criteria for SLE, with biopsy-proven class III, IV and/or V LN
* Active (new or relapsing) LN within the prior six months, with at least one of the following:
* Kidney biopsy with activity index \>2 and/or
* Active urinary sediment (\>5 RBCs, \>5 WBCs, or cellular casts)
* Receiving standard-of-care immunosuppression regimen for active LN, including mycophenolate, cyclophosphamide, belimumab, azathioprine, a calcineurin inhibitor, and/or B cell depleting therapies
* Recent or ongoing glucocorticoids use for active LN within the past 6 months
* Receiving standard-of-care antimalarial therapy and RAAS blockade, unless contraindicated
* Estimated ≥0.5 g/g 24 hr proteinuria or ≥0.3 mg/g 24 hr microalbuminuria at enrollment (on first morning urine)
* Ability to given informed consent
Exclusion Criteria:
* GFR \< 25 ml/min/1.73m2
* Acute kidney injury at study enrollment (\>50 percent rise in creatinine within 90 days)
* Type I diabetes, underweight (BMI \<18.5), active malignancy, active infection, or recurrent genitourinary infections
* For females: pregnancy, or desiring of pregnancy and not using contraception, or unable to use contraception
* Current use of \>1mg/kg/day prednisone equivalent
* Current or prior use of SGLT2 inhibitors or GLP-1 receptor agonists
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Karen H Costenbader, MD, MPH
- Email: kcostenbader@bwh.harvard.edu
- Phone: (617) 525-8785
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
TranspoCART19 CAR-T therapy in adults with refractory lupus nephritis
This trial tests whether a patient’s own CD19 CAR-T cells can be safely given and potentially help adults with lupus nephritis that isn’t responding to standard treatments.
-
Lupus Nephritis Care Pathway
A small group of adults with lupus nephritis will try a team-based care path that uses telemedicine and pharmacist-led support to help manage their treatment and see if it improves adherence and outcomes.
-
Initial glucocorticoid-dose harmonization in childhood lupus nephritis
This trial tests whether starting children with Lupus Nephritis on a lower or higher prednisone dose makes a difference in treatment outcomes.
-
See if empagliflozin helps kidney function in people with lupus nephritis
This study tests whether adding empagliflozin to standard care improves kidney function in adults with active lupus nephritis.
-
HB2198 for adults with moderate to severe lupus, including lupus nephritis and extra‑renal lupus
This trial will test whether two intravenous doses of HB2198 can safely reduce B cells and improve disease measures in adults with moderate to severe lupus, including lupus nephritis and extra‑renal lupus.
-
HSK39297 tablets for lupus nephritis
This trial will test whether once-daily oral HSK39297 (200 mg or 300 mg) is safe and well tolerated compared with placebo in adults with active lupus nephritis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.